MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1125225-12

Device Problems Kinked (1339); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant products: guide wire: sion; guide cath: mach1.Evaluation summary: the device was returned for analysis.The reported shaft kink was able to be confirmed.Additionally there was a tear found at the guide wire exit notch.Based on a visual inspection of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the information provided, the reported difficulties appear to be related to circumstances of the procedure and not a product quality issue with respect to manufacture, design or labeling.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.Based on the information reviewed, there is no evidence to indicate the presence a potential quality issue with respect to manufacture, design or labeling.(b)(4).

Event Description

It was reported that the procedure was to treat a mildly tortuous, moderately calcified and 90% stenosed posterior descending artery.Pre-dilatation was performed with a non-abbott balloon catheter.A 2.25 x 12 mm xience alpine stent delivery system was being advanced to the lesion when the shaft kinked.There was no resistance noted during advancement.The device was removed and another 2.25 x 12 mm xience alpine was successfully used to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.Returned device analysis revealed the shaft was torn at the guide wire exit notch.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5105429
• MDR Text Key: 26953828
• Report Number: 2024168-2015-05644
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 1125225-12
• Device Lot Number: 5032041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1